On 1 September, GMP manufacturing becomes mandatory for Japan's tablet and capsule functional foods, and every label already on shelves must carry a new medicine-interaction warning: the reform follows a scandal whose own hotline logged 416 death reports, of which the manufacturer has confirmed zero

Two transition periods, one deadline

Japan's Foods with Function Claims system, launched in 2015, lets a business self-notify a product's function claim to the CAA using its own scientific evidence, without the pre-market government review required for Tokutei Hoken (FOSHU) health foods. That light-touch design is what made the March 2024 recall of Kobayashi Pharmaceutical's Beni Koji Choleste Help so damaging: a self-notified supplement, later found contaminated with puberulic acid from blue mould, was linked to kidney damage in users, over 240 hospitalisations by mid-April 2024, and a wave of reported deaths that Japan's health ministry (MHLW) never fully resolved. The government responded not by scrapping the self-notification model but by bolting two mandatory layers onto it: a revised Food Labeling Standard, effective 1 September 2024, and a revised GMP notification for supplement-form FFC products. Both carried a two-year transition period. Both end on 1 September 2026, for every product already on the market, not just new notifications filed after that date.

The numbers behind 1 September

One number is how large the FFC catalogue was before the scandal hit, the base the deadline now applies to. The other two are the same underlying case, counted two different ways by two different parties.

The real subject: a reform that does not wait for causation to be settled

Coverage of a product-safety scandal usually assumes the regulatory response follows from the final casualty count: once investigators establish how many people a contaminated product actually harmed, the rule gets calibrated to match. The FFC reform breaks that sequence. Japan's health ministry has never closed the gap between the 113 deaths it counted as under investigation in August 2024 and the 416 death-related inquiries Kobayashi's own hotline had logged five months later, and the company's own most recent statement still confirms zero cases with an established causal link. None of that ambiguity paused the reform. The CAA built the revised Food Labeling Standard and the GMP notification on a fixed two-year clock starting in September 2024, and that clock runs out on 1 September 2026 regardless of where the casualty count eventually settles. The system self-notification model, which let a business certify its own function claim without pre-market government review, is precisely why the fix had to be structural rather than case-by-case: with no government approval step to tighten, the only lever left was to mandate how the product is made and how its label reads, for every product already on the market, not to wait on a number.

Why it matters for brands

For any brand selling a supplement, vitamin or functional-food product into Japan under an FFC notification, whether manufactured domestically or imported, 1 September 2026 is a full-catalogue compliance sweep, not a formality for new launches. Every SKU already carrying a function claim needs its packaging checked against the revised standard: the boxed FFC mark and notification number in the right position, plus the specific medicine-interaction and overdose warnings tied to that product's own functional ingredient, since the wording is not generic across the category. Separately, any tablet, capsule or concentrated-extract product needs its manufacturing site checked against the GMP mandate, and for a foreign brand that means confirming, product by product, whether its existing GMP certification, domestic or from another market, is recognised as equivalent, rather than assuming it automatically qualifies. The two obligations run on the same clock but are decided by two different facts about a product, its label content and its physical form, which makes this a data-classification problem before it is a manufacturing or artwork problem: a brand needs a per-SKU record of function-claim wording, ingredient-specific warning text and manufacturing-site GMP status to know which of its Japan-market products are actually ready for 1 September, rather than finding out from a CAA corrective notice after the fact.

Two ways to read 1 September